摘要
目的评估两种半胱氨酸蛋白酶抑制剂 C(Cystatin C,Cys C)检测系统的分析性能。方法 Cys C 分别采用 Dade Behring(德灵)公司出品的颗粒增强散射免疫比浊法(PENIA)和上海景源医疗器械有限公司出品的透射免疫比浊法试剂盒进行测定,评价的方法学指标为精密度、线性范围、抗干扰性、相关及偏倚。结果 Cys C 浓度在0.6～5.0 mg/L 时,两家试剂总变异系数(CV)<8%,检测线性范围为0.4～6mg/L。血红蛋白<10g/L,胆红素<300 mg/L,维生素 C<5 g/L 对两家试剂检测干扰<10%,在可接受范围内。甘油三酯(TG)≤20 mmol/L时德灵试剂检测不受影响(干扰<10%)。景源试剂 TG≥15 mmol/L 时低值血浆干扰>10%,高值血浆不受干扰。50份血样进行相关性分析的结果显示景源检测试剂盒与德灵的 PENIA 测定方法相关性良好(r=0.98,P<0.01)。线性回归分析经 Cusum 检验显示两方法间偏倚不具有统计学意义(P>0.05),但是景源测定结果较德灵结果偏低,平均偏倚为-0.16。对同一份样本景源与德灵测定 Cys C 的最小至最大偏差范围为1.1%～23%,平均为5.1%。结论两种方法的精密度、抗干扰性、线性范围符合要求,但是系统间测定结果存在一定偏差。
Objective To evaluate the performance of Cys C results among two detection system. Methods The particle-enhanced immunonephrometic assay was used in Dade Behring BNII. Immunoturbic assay was used in Hitachi 7170 to evaluate the JING＇ YUAN reagents. We compared the precison, linearity, interference, correlation, and calibrators agreement with Dade Behring BNII. Results The total CV of the samples that contain 0. 6 - 5.0 mg/L was less than 10%. The Dade Behring and JING＇YUAN method showed good linearity. Haemoglobin （ 10 g/L）, Bilirubin （ 300 mg/L） , Vitamin C（5 g/L） in the tested sample had no significant interference in the assay（ interference 〈 10% ）. The interference was no significant to Dade Behring when triglyceride ≤ 20 mmol/L. Triglycerides （ ≥ 15 mmol/L） has interference to JING＇YUAN reagents. Results of method correlated well with that of the Dade Behring BNII PENIA （r =0. 98, P 〈0. 01）. There have no significant deviation from linearity （P 〉0. 05） between JING＇ YUAN and Dade Behring reagents. Values were slightly lower than that from the Dade Behring BNII method, the mean bias was -0. 16. The bias range was 1.1% -23% between JING＇YUAN and Dade Behring for one sample. Conclusions The precision, linearity and interference test were suitable for routine Cys C measurement on automated biochemistry analyzer, but results has bias.
出处
《中华检验医学杂志》
CAS
CSCD
北大核心
2007年第11期1284-1287,共4页
Chinese Journal of Laboratory Medicine
